Mon.Dec 09, 2024

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FDA Refines Accelerated Approval Pathway with New Draft Guidance

XTalks

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.

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Reprieve for Chinese biotechs as BIOSECURE Act left out of key bill

Pharmaceutical Technology

Shares in WuXi AppTec, one of those implicated in the Chinese biotech blacklisting legislation, surged following the omission.

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Imfinzi receives NICE recommendation for lung cancer treatment

Pharma Times

Trial results lead to new treatment option for lung cancer

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Citryll gains Series B funds to develop NET-targeting antibody

Pharmaceutical Technology

Citryll has secured an oversubscribed Series B funding round, raising 85m ($89.8m) to advance the clinical development of CIT-013.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Poolbeg Pharma presents positive results for POLB 001

Pharma Times

promising pre-clinical data on preventing cytokine release syndrome

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Priority FDA review given to AstraZeneca’s Imfinzi sBLA for MIBC

Pharmaceutical Technology

The US FDA has granted priority review to AstraZeneca's sBLA for Imfinzi (durvalumab) for muscle-invasive bladder cancer (MIBC) treatment.

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More Trending

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Daiichi Sankyo secures breakthrough designation for NSCLC treatment

Pharmaceutical Technology

The breakthrough designation for Daiichi Sankyo comes after early pooled results from two ongoing trials finding the drug was well tolerated.

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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.

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Novo Holdings’ acquisition of Catalent gains EC approval

Pharmaceutical Technology

Novo Holdings, the investment arm of the Novo Nordisk Foundation, has gained approval from the EC for its acquisition of Catalent.

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TrialKit AI: Revolutionizing Clinical Research Analytics with AI

Crucial Data Soutions

December 9, 2024— Crucial Data Solutions is proud to announce that our groundbreaking innovation, TrialKit AI, has been recognized with. The post TrialKit AI: Revolutionizing Clinical Research Analytics with AI appeared first on Crucial Data Solutions.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Innovative Buffer Management Solutions: ZETA’s Modular Buffer Inline Conditioning System

Pharmaceutical Technology

How to increase efficiency and flexibility in buffer production for biopharmaceutical manufacturing? ZETA presents an innovative solution that saves space and reduces costs. Learn more about the future of buffer production!

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From High Maintenance to High Efficiency: The Power of an Optimized CTMS

ACRP blog

This is a sponsored message. Clinical Trial Management Systems (CTMSs) are software platforms that provide clinical research sites and research study staff with the ability to manage all operational aspects of a clinical trial, both at the study protocol level and participant level. A CTMS platform can help streamline study start-up processes, provide real-time visibility into the status of a study, improve collaboration through automated workflows, and optimize financial management processes.

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Pharmaceutical Technology Excellence Awards 2024: Image Analysis Group

Pharmaceutical Technology

Image Analysis Group is a winner in the Innovation category in the 2024 Pharmaceutical Technology Excellence Awards.

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Did Industry Fumble the DSCSA Deadline?

Pharmaceutical Commerce

Because of the potential for product shortages at pharmacies, the FDA has not only given industry more time for compliancebut time to catch up on boosting the supply chains interoperable efforts.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Bringing Engineering to a New Level: ZETA’s Integrated Approach

Pharmaceutical Technology

ZETA provides the best-in-class services and customised solutions to specific problems of its customers.

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Examining Launch, Post-Launch Price Developments in the United States and Europe

Pharmaceutical Commerce

A cohort study of cancer drugs analyzes where the priorities of pricing policies should lie.

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Humira Biosimilar Price War Update: Should We Be Glad that CVS Health and Express Scripts Are Using Private Label Products to Pop the Gross-to-Net Bubble? (rerun)

Drug Channels

This week, Im rerunning some popular posts while I prepare for Fridays Drug Channels Outlook 2025 live video webinar. Click here to see the original post. During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. The Humira biosimilar market just took another step forwardbut remains far from its ideal state.

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Caught Beneath the Surface: The Hidden Potential of Patient Data

Pharmaceutical Commerce

Filling the gaps in the patient journey within an increasingly complex data environment.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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HPM and Riparian to Co-Host Webinar on CMS Misclassification Penalties Rule

FDA Law Blog

On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. (See our post on this rule here.) The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements.

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The Gap in DSCSA Readiness

Pharmaceutical Commerce

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, predicts the probability that these DSCSA compliance deadlines put forth by the FDA will be met.

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Ticktock: The EAA Is Coming. Are You Ready? 

Intouch Solutions

You might be wondering what EAA stands for and why it matters to your brand. Its an abbreviation for the European Accessibility Act , an initiative by the European Union (EU) to make products and services more accessible to individuals with disabilities and the elderly across the EU. This directive highlights the EU and its 27 member states commitment to accessibility, as demonstrated by their ratification of the United Nations Convention on the Rights of Persons with Disabilities.

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Pharma Pulse 12/9/24: Embracing AI in Pharma, Millions Could Benefit from Magic Mushrooms & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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DDW Highlights: 9 December 2024

Drug Discovery World podcast

The latest episode of the DDW Highlightspodcast is now available to listen to and watch below. DDWs Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. This weeks leading news stories all shine a light on innovation within drug discovery, including a potential best-in-industry weight loss drug, a gold-based compound that shrinks tumours by 82%, and a second-generation CAR-T therapy.

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